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FDA 510(k), K132931, APOLLO SYSTEM
FDA 510(k), K132931, APOLLO SYSTEM
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510(K) Number: K132931
Device Name: APOLLO SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: endoscope, neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 09/18/2013
Decision Date: 01/17/2014
Regulation Medical Specialty: Neurology
Device Name: APOLLO SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: endoscope, neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 09/18/2013
Decision Date: 01/17/2014
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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